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Wowser. Did you write this:
"What they don't tell you - Zonagen. Where to begin? First notable;
their marketing partner, Shering Plough, also a presenter at the
conference, deferred all discussion of ZONA's erectile dysfunction
product, Vasomax, to ZONA. Guess they don't want to be named
co-defendants in the dozen-or-so lawsuits waged against ZONA
alleging fraud among other things.
As for the actual ZONA presentation, the CEO stated that an NDA
will be filed before the end of June 98, and will undergo at least a
year review at FDA. He also stated that SGP made ZONA revamp
its style for NDA submissions, thus the delay in the 350 volumes
going to FDA. Didn't we write this to the bulls on the ZONA SI
thread last year?
Surprisingly, the CEO only mentioned Vasomax for male erectile
dysfunction for 5 minutes of the 25 minute discussion. He did go
on to say for an equal amount of time that they are looking to test
Vasomax in conjunction with other MED drugs. Hmmm. At no
point did he mention the pharmacokinetcs of Vasomax or
comment on its time to onset of erection.
In the breakout session, we asked him why he omitted this key
discussion from both his talk and his white paper, issued in
December 1997. With tape recorders rolling, he said that the
white paper clearly states that the onset of erection is 30-45
minutes. We are still looking for that discussion and invite anyone
to cite chapter and verse of where this parameter is mentioned
(ZONA only talks about "rapid onset of action" on page 4 - not
exactly a quantitative measure of anything).
We equate omission of this discussion, or any mention of the
pharmacokinetics of oral phentolamine, to be a deal breaker. The
problem is that since the FDA submission is six months later
than when ZONA said it would be filed last year, the FDA does not
have to give it priority review since Viagra is already approved. As
such, a lot can happen with this stock in the interim, especially
given that ZONA still can buy back up to $6mm worth of shares
itself. The ZONA situation accentuates further that the gap
between the fundamentals of a company and the price of its stock
can assume arbitrary breadths until the FDA day of reckoning.
Don't believe me? Answer this question. What do ERGO
Sciences and Frank Sinatra have in common today? " |
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